Determination of the effect of inhalation of orange extract and lavender on dental anxiety in dental clinic of Shiraz in 2017.
Design
Randomized clinical trial, Three arm parallel group, two side blinded
Settings and conduct
This randomized clinical trial will do in Shiraz milad dentistry clinic. En In order to blind the investigator, the medications (extracts) were named A, B, and C.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- People between the ages of 18 and 60 years.
2- At least, have Lower secondary education certification
3- Any history of allergy to aromatic agents
4- No history of discomfort in the sense of smell.
5- Having informed consent to participate in the study
6- coming to the dentistry clinic just For examination, root canal treatment or tooth repairmen
Exclusion criteria:
1- Pregnancy
2- Using sedative medications before going to the clinic
3- known cases of psychiatric disorders
4- Positive history of the sensitivity response to the administrated drugs in the study
5- known cases of mental and neurological disorders
Intervention groups
Group 1: Using the essential oil of the drug A for 20 minutes
Group 2: Using the essential oil of the drug B for 20 minutes
Group 3: Using the essential oil of the drug C for 20 minutes
Main outcome variables
Anxiety score in patients who referred to Shiraz Milad dentistry clinic
General information
Reason for update
Acronym
TPM
IRCT registration information
IRCT registration number:IRCT20150825023753N4
Registration date:2018-01-24, 1396/11/04
Registration timing:retrospective
Last update:2018-01-24, 1396/11/04
Update count:0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
Comparison of the effect of inhaling the ،essence of orange and lavender on client's dentistry anxiety in Shiraz Dentistry Clinic, 2017
Public title
Effect of aromatherapy by essence of lavender and orange on dentistry anxiety .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 18 and 60 years.
At least, have Lower secondary education certification
any history of allergy to aromatic agents
No history of discomfort in the sense of smell.
Having informed consent to participate in the study
For examination, root canal treatment or tooth filling only
Exclusion criteria:
Pregnancy
Using sedative medications before going to the clinic
known cases of psychiatric disorders
Positive History of the Sensitivity Response to the Drugs Involved in the Study
Known cases of mental and neurological disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink was used to create a randomization table by a block size of six.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the investigator, the medications (extracts) were named A, B, and C. The researcher asked the researcher for the impregnated cotton with the essential oils (2 drops of lavender essential oil, orange, sesame, with the help of the researcher on a piece of cotton) in boxes labeled C, A , B, and placed them at the disposal of patients. (Scholar blinding). Subsequently, they were asked to take the cotton at a distance of 3 cm from the eye. The codes listed for statistical analysis were employed. Then the statistical analyzer of the essence of the essential oils was unknowing for the patients (statistical analyzer blinding).
Placebo
Used
Assignment
Parallel
Other design features
______
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Bushehr University of Medical scienes
Street address
Faculty of Nursing and Midwifery, University of Medical Science, Behnani Street, Busher City,
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2017-07-21, 1396/04/30
Ethics committee reference number
IR .BPUMS.REC.1396.86
Health conditions studied
1
Description of health condition studied
Dental Anxiety
ICD-10 code
F40.2
ICD-10 code description
Specific (isolated) phobias
Primary outcomes
1
Description
Anxiety Score
Timepoint
Before and after
Method of measurement
Using Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Aromatic odor of 0.1 cc (two drops) impregnated cotton with orange extract made by Barij Essence Company for 20 minutes with a distance of 3 cm from the patient nose before dentistry intervention
Category
Treatment - Drugs
2
Description
Aromatic odor of 0.1 cc (two drops) impregnated cotton with lavender extract made by Zarband Company for 20 minutes with a distance of 3 cm from the patient nose before dentistry intervention
Category
Treatment - Drugs
3
Description
Aromatic odor of 0.1 cc (two drops) impregnated cotton with sesame oil (for placebo) made by Nosahd Company for 20 minutes with a distance of 3 cm from the patient nose before dentistry intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Milad Shiraz
Full name of responsible person
Dr. Ali Mohammad Salehi
Street address
Milad Dentistry Clinic. Alam Square Aveiroud Street.Shiraz City
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3626 2843
Fax
Email
samahasanshahi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahreini
Street address
Faculty of Nursing and Midwifery Bushehr University of Medical Sciences Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0187
Fax
+98 77 3345 0187
Email
msdbahreini@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
mmparvizi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr.Masoud Bahreini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Nursing and Midwifery, Bushehr University of Medical Sciences, Bahmani Street, Busher City
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0187
Fax
Email
msdbahreini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Samane Hasanshahi
Position
Student ,Master of Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
No. 383, Tahmasebi Street; Golestan Blvd, Shiraz City
City
Shiraz
Province
Fars
Postal code
7145746355
Phone
+98 71 1225 5761
Email
samahadanshahi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
sending Email to the researchers
What processes are involved for a request to access data/document